Olympus WA69310MRecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Jaws insert "HICURA", 5 x 330, Johann, monopolar · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04042761079143), received between Feb 22, 2023 and May 5, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Flare or Flash1
- Material Integrity Problem1
- Mechanical Problem1
- Structural Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 5, 2026Break
IT WAS REPORTED DURING PRE-USE INSPECTION, THE TIP OF THE JAWS WAS DISTORTED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25083950 ↗MalfunctionAug 13, 2025Structural Problem; Structural Problem
IT WAS REPORTED MONOPOLAR CLINCHING JAWS INSERT'S JAW IS MISALIGNED AND THAT BOTH ENDS ARE MISALIGNED WHEN PINCHING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22795775 ↗MalfunctionDec 29, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED, THE SUBJECT DEVICE HAD DAMAGED JAWS OF TOOLS THAT DID NOT GRASP TISSUE. TOOLS USED FOR LAPAROSCOPIC CHOLECYSTECTOMY, HERNIA AND BOWEL SURGERY. HIGH GRASPING POWER WAS NOT USED DURING THESE OPERATIONS. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21032417 ↗MalfunctionDec 5, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THE HICURA JAWS INSERT FORCEPS DO NOT HOLD TISSUE. THE LOCK IN THE HANDLE FASTENS BUT THE TISSUE GRIPPED BY THE FORCEPS SLIDES OUT WHEN THE INSTRUMENT IS MANIPULATED. THE ISSUE WAS FOUND DURING A LAPAROSCOPIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20855621 ↗MalfunctionFeb 22, 2023Flare or Flash; Flare or Flash
IT WAS REPORTED TO OLYMPUS THAT DURING A BARIATRIC OPERATION ON JANUARY 20, 2023, THE CONNECTION BETWEEN THE JAW AND THE STEM ¿FLARED¿ AND FELL INTO THE SURGICAL FIELD. THE PATIENT IS FINE, THERE ARE NO INJURIES TO INTERNAL ORGANS. THERE WAS NO INJURY OR HEALTH DAMAGE DUE TO THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16423087 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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